GUEST COLUMNISTS

• Tackling The Cell & Gene Therapy Sector's Practical Post-Approval Problem

  As the regulatory landscape continues to evolve, cell and gene therapy companies must plan post-approval change programs with regulatory monitoring built in from the start.

• Why Your MES RFP Is Failing Before It Starts

  Many manufacturing execution system requests for proposals fail. Not because vendors cannot deliver or the tech is immature, but because the requirements are written backward.

• Here's How FDA's Accelerated Approval Pathway Has Evolved Since '24

  FDA's accelerated approval guidance kicked off a rebalancing of new drug approval pathways. Since its 2024 release, the agency has been building on it in a few key areas.

• Gaining An Edge In GLP-1 Production

  The shortage-driven production of GLP-1 drugs of the past few years is giving way to a long-term operation model characterized by digital enablement and supply chain resilience.

• How Generic Pharma Manufacturers Can Rebuild Margins Inside The Four Walls

  The pricing dynamics for generic drugs turns formerly attractive products into high-volume, low-margin commodities. Lean and Six Sigma in four key areas can unlock efficiencies.

• Causal Mechanism And Effect Analysis (CMEA): FMEA's Simpler, Effective Alternative

  This article describes causal mechanism and effect analysis (CMEA) as an alternative to failure mode and effect analysis (FMEA) for analyzing and managing the industry’s risks.

• The Stepwise Path Lilly Mapped From Paper To Digital Logbooks

  Eli Lilly and Company started at the front lines, on the shop floor gathering operator input, when switching from paper to digital logbooks.

• Minimizing Regulatory Risk For Biologics Manufacturing Changes

  Any manufacturing process change for a biologic can raise comparability questions. Here’s a practical, action-oriented strategy to ensure health authorities are satisfied.